10.4.1 Labelling of shelf/multi-unit packs shall comply with EN 1041.
10.4.2 The labelling of shelf/multi-unit packs shall include the following:
a) a description of the contents;
b) the designated size in accordance with 5.1.1, expressed in accordance with one of the following examples. Length may also be designated in centimetres:
— 6 mm × 500 mm, or
— 6 mm (18F) × 500 mm, or
— diameter 6 mm (18 F), length 500 mm;
c) the name and/or trademark and address of the manufacturer and/or supplier;
d) the batch number preceded by the word “LOT”;
e) where appropriate, an indication of the date by which the catheter should be used, expressed as the year and month;
f) appropriate instructions on preparation for use;
g) where appropriate, the word “STERILE” and the method of sterilization;
h) where applicable, instructions for cleaning and disinfection or sterilization, and the maximum number or period of reuses shall be marked on the suction catheter package or on an insert;
i) for suction catheters not intended for reuse, the words “single use” or equivalent.
Annex A (informative)
Rationale
General
This annex provides a concise rationale for the important requirements of this International Standard and is intended for use by those who are familiar with the subject of this International Standard but who have not participated in its development. An understanding of the reasons for the main requirements is considered essential for its proper application. Furthermore, as clinical practices and technologies change, it is believed that rationales for the present requirements will facilitate any revisions of this International Standard necessitated by those developments.
The clauses and subclauses in this annex have been so numbered to correspond to the clauses and subclauses in this International Standard to which they refer. The numbering is, therefore, not consecutive.
Clause 2 Normative references
ISO 594-1 and ISO 594-2 are intended to be replaced by ISO 80369-7.[7]
Subclause 3.3 closed suction catheter
Closed suction catheters are used for endotracheal or artificial airway suctioning to minimize disturbance of the VBS. Closed suction catheters are provided with a protective sleeve to protect the user and the immediate environment (room surfaces, room air) and reduce the risk of contamination with secretions.
At the time of publication of this International Standard, it was common practice in critical care areas to use a closed suction catheter during simultaneous mechanical ventilation of a patient. Use of a closed suction catheter allows uninterrupted mechanical ventilation without disconnection of the VBS from the tracheal tube, tracheostomy tube or other airway device. This is in contrast to the use of a traditional open suction catheter which require the opening or disconnection of the VBS before the application of the subatmospheric pressure on the respiratory tract.
When used as intended, an in-line or closed suction catheter and related suction equipment become an accessory to the ventilator and an extension of the VBS. When a VBS is equipped with a suction catheter adaptor, the connector at the patient end of the closed suction catheter adaptor becomes the ‘new’ patient connection port of the VBS.
Subclause 3.10 patient end adaptor
All closed suction catheters are enclosed within a protective sleeve and a patient end adaptor designed to connect to the airway and the breathing set of the VBS.
For closed suction catheters, examples of patient end adaptors may include a T-piece adaptor, Y-piece adaptor, a 3-way breathing system connector, a swivel adaptor, and other specialized adaptors for co- axial, multiple tubes, and bifurcated tubes. See also Figure 2.
Subclause 3.23 suction catheter connector
In this edition, the new term suction catheter connector replaces what was described previously with many different terms as the machine end, the adaptor, the male end or the connector in various subclauses of the previous edition, i.e. ISO 8836:2007. Consolidation of these confusing terms is intended to clarify the requirement of this International Standard.
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Suction catheter devices should be designed in such a way that satisfies the performance, safety, clinical, and usability needs of patients and users.
This section has been revised to include basic safety and essential performance and risk management principles associated with suction catheters. The need for a risk management file is a well recognized process through which the manufacturer of a medical device can identify hazards associated with a medical device, estimate and evaluate the risks associated with these hazards, control these risks, and monitor the effectiveness of that control. Clinical evaluation may also be necessary to confirm the adequacy of the controls. See ISO 14971 for additional information.
Some elements of device design, as appropriate, may be evaluated using biophysical or modelling research whose validity has been established. Biophysical or modelling research includes the application of physics and engineering to biological processes and may include anatomical modelling or other means to simulate clinical use.
Attention is drawn to the consideration of disclosure of specific labelling and instructions for intended use that might deviate from the currently accepted medical practice.
Subclause 5.2 Dimensions
The materials used for the manufacture of suction catheters should allow construction of a suction catheter with the thinnest possible wall, which at the same time maintains resistance to collapse and kinking.
Subclause 7.3.6 Suction catheter connector
It is understood that small-bore connector systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. For example, the possibility of the misconnection of a small-bore connector to a specialized patient-access port can still exist. Specialized patient-access ports often require the use of flexible materials which are intended to permit access by a range of medical devices or accessories, such as endoscopes, bronchoscopes and surgical instruments. These access ports can permit interconnection with some small-bore connectors. The risks associated with the use of these specialized patient-access ports are not addressed by this International Standard. Manufacturers of medical devices or accessories and the committees responsible for the development of standards for medical devices or accessories that incorporate these specialized patient-access ports will need to assess these risks.
Subclause 7.3.8 Vacuum control device
To reduce the hazards associated with residual vacuum all suction catheters used in the respiratory tract must be provided with a vacuum control device.
Subclause 7.4.2.7 Internal volume
Internal volume is important because the design of the patient connection port should minimize dead space to reduce the volume of rebreathed gases. The design of the patient connection port should also minimize the accumulation of secretions.
Subclause 7.4.4.2 Vacuum control device leakage
Clinicians have noted the transmission of fluids from the vacuum control device during use. Fluids can contain pathogens. It is important, therefore, that these devices should not leak potentially contaminated fluids into the environment during their use. The vacuum control device may be a site of such a leak in the closed position, the open position, and during transition between the two states.
The positive pressure from the ventilator may potentially force contaminated fluids through the valve, particularly in the setting of a blockage in the suction line. A static leak test only assesses leakage in the closed position. The manufacturer should ensure that the vacuum control valve remains leak-free in all positions, even when the machine end is blocked and positive pressure applied to the patient end.
Subclauses 8.3 and 8.4
Test methods of vacuum control device performance on closed suction catheters are based on historical methods developed by manufacturers of these devices. ISO/TC 121/SC 2 discussed at length alternate test methods to assess leakage in simulated clinical conditions. ISO/TC 121/SC 2 agreed that the test methods described in this International Standard are sufficient to meet needs at the time of publication.
Subclauses 8.4 and 8.5
Requirements have been added to reduce the risk associated with low delivered tidal volumes which are attributed to leakage, resistance, and internal volume of VBS accessories. Because the closed suction catheter is an accessory of a breathing system, the same functional performance requirements that apply to the breathing set also apply to the closed suction catheter.
See ISO 5367 and ISO 80601-2-12:2011, Annex A (rationale) for more information.
Subclause 8.4 Leakage
Leakage limits are approximately 30 % of the ventilator and anaesthetic breathing system limits and 100 % of the breathing set limit.
Table 4 recognizes that manufacturers use statistical methods in developing and testing their devices, and that almost all devices in a manufacturing run have a leakage much lower than those shown in the table. Furthermore the variability in leakage from the assembled system is proportional to the square root, rather than the sum of the number of devices placed in the circuit. Most failures attributable to leaks occur as a result of a fault condition in the system, rather than a stacking of individual leaks.
While it is necessary to have some figure against which a manufacturer can test their products, this International Standard recognizes the variability inherent in the manufacturing process, and that it is statistically unlikely that every device placed in the VBS will leak at the maximum allowable rate, and thus exceed the ventilator budget. These values have been placed at 30 % of the ventilator budget, being approximately the square root of 10, so that it is unlikely that even if 10 devices were placed in the circuit that the budget would be exceeded.
Subclause 8.5 Resistance to flow
Resistance limits are 15 % of the ventilator and anaesthetic breathing system limits and 100 % of the breathing set limit.
Subclause 8.6 Radiopacity
The requirement for radiopaque markers is intended to allow visualization of the suction catheter when verification of the depth of intubation is required.
Subclause D.2.2
Temperature conditions are the same as the normal operating and test conditions for breathing sets and heated humidifiers. See ISO 5367 and ISO 8185.[5]
Annex B (normative)
Test method for security of attachment
B.1 Principle
The security of attached components is tested by applying an axial separation force to the components.
B.2 Apparatus
B.2.1 Means of conditioning the suction catheter at (23 ± 2) C at (50 ± 20)% relative humidity and carrying out the test under the same conditions.
B.2.2 Means of separately securing the components under test and separating the two at a rate of (200 ± 20) mm/min and measuring and recording the axial separation force applied.
B.3 Procedure
B.3.1 Condition the suction catheter at (23 ± 2) C and at (50 ± 20)% relative humidity for 1 h and carry out the test under the same conditions.
B.3.2 Separate the components under test at a rate of (200 ± 20) mm/min and observe whether the component under test becomes detached from the other component before the appropriate minimum force, given in Table 2 or Table 3 as appropriate, has been reached.
B.4 Expression of results
Record whether the components become detached before the appropriate minimum force, given in Table 2 or Table 3 as appropriate, has been reached.
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Annex C (normative)
Measurement of residual vacuum
C.1 *Principle
The effectiveness of the vacuum control device as a means of relieving vacuum at the patient end is tested by measuring the residual vacuum at the tip of the catheter with the vacuum control device in the relief position, while suction is applied to the machine end of the catheter.
C.2 Apparatus
C.2.1 Flowmeter, capable of measuring a flow of 30 l/min to an accuracy of within ±5 % and a resistance to flow of less than 0,1 kPa at 30 l/min.
C.2.2 Adjustable vacuum pump.
C.2.3 Manometer, to an accuracy of ±0,01 kPa (0,1 cmH2O).
C.3 Procedure
C.3.1 Assemble the apparatus, as shown in Figure C.1, with the flowmeter fitted to the exit of the vacuum pump, ensuring an airtight fit between the catheter and the manometer.
C.3.2 For open suction catheters, open the catheter vacuum control device to the vacuum relief position. Switch on the vacuum pump and adjust the applied vacuum until a flow of 30 l/min is indicated on the flowmeter.
C.3.3 For closed suction catheters, detach the manometer, open the vacuum control device, switch on the vacuum pump and adjust the applied vacuum until a flow of 30 l/min is indicated on the flowmeter, then close the vacuum control device and attach the manometer.
C.4 Expression of results
Express the residual vacuum, in kilopascals, as indicated by the reading on the manometer.
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Key
1 flowmeter 2 vacuum pump
3 suction catheter with vacuum control device 4 manometer
X detail of suction catheter shaft sealed to manometer
Figure C.1 — Apparatus for residual vacuum test
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Annex D (normative)
Method of testing leakage
D.1 Principle
Leakage is tested by applying and maintaining an internal set pressure by introducing air into the patient end of the patient connection port of a closed suction catheter in the “off” position and all other connection ports blocked and recording the flow of air necessary to maintain that pressure.
D.2 Apparatus
D.2.1 Means of applying and maintaining for 5 min an internal gas pressure of (6 ± 0,3) kPa [(60 ± 3) cmH2O].
D.2.2 *Means of conditioning the closed suction catheter, and carrying out the test procedure at a temperature of (23 ± 2) °C and (42 ± 3) °C.
D.2.3 Means of recording the flow of air, required to maintain the specified internal gas pressure in the closed suction catheter being tested, accurate to within ±5 % of the flows specified in 8.4.
D.3 Procedure
D.3.1 Carry out the test procedure at a temperature of (23 ± 2) °C and (42 ± 3) °C after the closed suction system has been conditioned for at least 1 h.
D.3.2 Attach the means of applying and maintaining an internal pressure according to D.2.1 to the closed suction catheter. Close the respiration and patient connections which are not used and the vacuum control device.
D.4 Expression of results
The flow required to maintain the specified internal gas pressure shall be expressed in ml ã min−1.
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Annex E (informative)
Hazard identification for risk assessment
E.1 General
Identified hazards listed in E.2 and E.3 below represent those associated with the use of suction catheters published by the American Association for Respiratory Care (AARC) and RESPIRATORY CARE in a comprehensive review of clinical articles published between January 1990 and October 2009 using MEDLINE, CINAHL, and Cochrane Library databases, and a total of 114 clinical trials, 62 reviews and 6 meta-analyses on endotracheal suctioning.[9]
NOTE This list is not intended to be comprehensive for all devices within the scope of this International Standard, but it provides guidance for risk assessment. Not all hazards will apply to each type of suction catheter.
E.2 Patient harm associated with the use of suction catheters
E.2.1 Patient harm associated with the placement, removal and use of suction catheters a) decrease in dynamic lung compliance and functional residual capacity
b) atelectasis
c) hypoxia/hypoxemia
d) tissue trauma to the tracheal and/or bronchial mucosa e) bronchoconstriction/bronchospasm
f) increased microbial colonization of the lower airway
g) changes in cerebral blood flow and increased intracranial pressure h) hypertension
i) hypotension
j) cardiac dysrhythmias
E.2.2 Patient harm associated with routine use of normal saline instillation and suction catheters
a) excessive coughing
b) decreased oxygen saturation c) bronchospasm
d) dislodgement of the bacterial biofilm colonizing the tracheal tube into the lower airway e) pain, anxiety, dyspnea
f) tachycardia
g) increased intracranial pressure
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E.2.3 Patient or user harm associated with toxicity a) Allergy, including allergy to natural rubber latex b) Tissue sensitivity, inflammation, necrosis c) Systemic absorption of toxic substances
d) Pollution of the immediate surrounding environment e) Leakage of ventilatory gas or aesthetic gases and vapours
E.3 Hazardous situations and hazards associated with the use of suction catheters
a) Loss of function caused by:
1) obstruction of the lumen, debris or fluid in the lumen;
2) kinking;
3) fracture of the shaft of the suction catheter; 4) failure of the suction valve;
5) undetected leak;
6) excessive resistance;
7) elevated temperature leading to softening of materials, weakening connections, leakage.
b) Incorrect size for a specific patient caused by:
1) inadequate or incorrect disclosure of size requirements by manufacturer;
2) patient variability
c) Loss of ventilator function and/or accuracy:
1) undetected leak;
2) excessive breathing resistance;
3) rebreathing of exhaled gases due to excessive internal volume.
d) Connections
Difficulty of connection and disconnection of swivel connectors may conflict with the requirements for security of connection.
NOTE See ISO 14971 for additional information on harm, hazardous situations, and hazards in the risk analysis process
Bibliography
[1] ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
[2] ISO 5361, Anaesthetic and respiratory equipment — Tracheal tubes and connectors
[3] ISO 5366-1, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 1: Tubes and connectors for use in adults
[4] ISO 5366-3, Anaesthetic and respiratory equipment — Tracheostomy tubes — Part 3: Paediatric tracheostomy tubes
[5] ISO 8185, Respiratory tract humidifiers for medical use — Particular requirements for respiratory humidification systems
[6] ISO/TR 11991, Guidance on airway management during laser surgery of upper airway
[7] ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7:
Connectors with 6% (Luer) taper for intravascular or hypodermic applications3)
[8] ISO 80601-2-12:2011, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
[9] AARC Clinical Practice Guidelines-Endotracheal Suctioning of Mechanically Ventilated Patients With Artificial Airways 2010. Respir. Care. 2010, 55 () pp. 758–764
3) To be published.